FLEXTRANS

Culture Media, Non-propagating Transport

BAXTER DIAGNOSTICS, INC.

The following data is part of a premarket notification filed by Baxter Diagnostics, Inc. with the FDA for Flextrans.

Pre-market Notification Details

• Device ID: K935987
• 510k Number: K935987
• Device Name: FLEXTRANS
• Classification: Culture Media, Non-propagating Transport
• Applicant: BAXTER DIAGNOSTICS, INC. 2005 NW SAMMAMISH RD. Issaquash, WA 98027
• Contact: Nancy Mallinak
• Correspondent: Nancy Mallinak; BAXTER DIAGNOSTICS, INC. 2005 NW SAMMAMISH RD. Issaquash, WA 98027
• Product Code: JSM
• CFR Regulation Number: 866.2390 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1993-12-14
• Decision Date: 1994-08-15

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
05391516747394	K935987	000
05391516747387	K935987	000